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HSE looking into whether 'special arrangement' possible for access to severe pregnancy sickness drug

Irish Pharmacy Union has said exceptional arrangements to fund the drug in individual cases should be put in place.

THE HSE HAS asked a medicine management group to “examine the appropriateness and feasibility of a patient specific arrangement” that would make a pregnancy sickness drug available to women who need it. 

The drug, known as Cariban, is currently unavailable on the drugs payment scheme or medical card.

Women impacted by severe vomiting, known as Hyperemesis Gravidarum or HG, have called for the State to reimburse the costs of Cariban, which can cost up to €3,000 over the course of a pregnancy. 

HG can profoundly debilitate women, and while women suffer from regular morning sickness (which can actually occur at any time of the day) HG is a lot more serious. 

Health Minister Stephen Donnelly has said the State can not reimburse the cost of the drug, despite Cariban being prescribed and available in the Coombe, Rotunda and Holles Street maternity hospitals, as the Health Products Regulatory Authority (HPRA) has advised that the drug is currently not licensed for use in Ireland. 

The Journal spoke to a number of women previously about their experiences dealing with HG, and how Cariban was the only treatment that worked for them. 

The HSE said last week that only licensed products are added to the reimbursement list in line with the Health (Pricing and Supply of Medical Goods) Act 2013, which is why women cannot get the drug on the drug payment scheme or medical card. 

“Therefore, as Cariban is an unlicensed product in Ireland, it is not reimbursable under the community drug schemes,” said the spokesperson. The only way the drug can be added is for the manufacturers to file an application for a licence approval, it said. 

The Irish Pharmacy Union (IPU) told The Journal that it is calling on the manufacturers of Cariban to apply for a product authorisation on the Irish market so that the HSE is in a position to reimburse it in the normal way through the medical card and drug payments schemes. 

It added:

In the meantime, pending an Irish product authorisation, the HSE should put in place exceptional arrangements to fund the drug in individual cases.

The charity Hyperemesis Ireland, which has been campaigning for women to get access to the drug, has stated that several pharmacists have contacted it to say a drug can be unlicensed and reimbursed by the State. 

The Journal asked the HSE whether unlicensed drugs, such as Cariban, can be reimbursed. 

In response, the HSE said it has developed a national framework for access to medicinal products not currently on the reimbursement list through Discretionary Hardship Arrangements in exceptional cases.

“However, Cariban is considered to be a food supplement rather than a medicinal product in Ireland. Therefore it cannot be considered for reimbursement as an Exempt Medicinal Product under the GMS and Community Drug Schemes, or reimbursement under Discretionary Hardship Arrangements,” it said in a statement. 

However, the HSE added that it has now “asked the Medicines Management Programme (MMP) to examine the appropriateness and feasibility of a patient specific arrangement” for the drug Cariban. 

The MMP works with the National Medicines Information Centre (NMIC) and the National Centre for Pharmacoeconomics (NCPE) and the HSE-Primary Care Reimbursement Service to deal with issues such as access to medicines and overall expenditure on medicines. 

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